A Descriptive Study on Patients With Bipolar Disorder in Rwanda
1 other identifier
observational
400
0 countries
N/A
Brief Summary
The aim is to provide a comprehensive assessment regarding the service provision and the accessibility to intensive mental health care in Rwanda
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedDecember 17, 2020
December 1, 2020
12 months
December 4, 2020
December 15, 2020
Conditions
Outcome Measures
Primary Outcomes (8)
Diagnoses
Psychiatric diagnoses including both primary diagnosis, secondary diagnosis and somatic comorbidity.
1 year
Diagnostic delay
Age of individual at onset of symptoms and age when diagnosed with bipolar disorder.
1 year
Number of previous psychiatric hospitalisations
Numerical value of the previous psychiatric hospitalisations.
1 year
Number of previous crises
Numerical value of the previous crises defined as an episode of depression or mania or hypomania.
1 year
Types of medical treatment provided
What type of medical treatment is provided, including brand name, administration and dosage.
1 year
Medical Adherence
Medication Adherence Rating Scale (MARS) will be used to assess beliefs and barriers to medication adherence. Total scores on the MARS may range between 0 and 10, with a higher score indicating better medication adherence.
1 year
The referral pathways
Who initiated the first contact, who did you seek for help, what kind of help was provided, percent of patients who came in contact with traditional leaders.
1 year
Degree of internal stigma
Internalized Stigma of Mental Illness Inventory - 9-item Version (ISMI-9) will be used to assess self-stigma. The resulting score should range from 1 to 4. A score ranging between 1.00-2.50: does not report high internalized stigma vs. a score ranging between 2.51-4.00: indicating high internalized stigma.
1 year
Interventions
A questionnaire will be delivered by the health care providers at Ndera Hospital, Kigali, Rwanda or CHUK, Hospital, Kigali, Rwanda. The questions will explore the patient's clinical characteristics, the current treatment and their experience with the mental health care system.
Eligibility Criteria
Outpatients with bipolar disorder in Rwanda
You may qualify if:
- A diagnosis of Bipolar Disorder type I or II that meets DSM-V diagnostic criteria
- Age ≥ 18 years
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- University of Rwandacollaborator
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospitalcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Per Kallestrup, Prof.
University of Aarhus
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2020
First Posted
December 17, 2020
Study Start
January 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
December 17, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share